Healthy Skepticism Library item: 1569
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Publication type: news
The Bureau of National Affairs, Inc
Bush Signs Pediatric Incentive Bill Extending Exclusivity Provision Until 2007
2002 Jan 9
Full text:
President Bush on Jan. 4 signed into law a bill reauthorizing until 2007 the pediatric exclusivity incentive, which gives drugmakers an additional six months of market exclusivity for testing their drugs in children (Pub. L. No. 107-109).
The reauthorized law, the Best Pharmaceuticals for Children Act (S. 1789), contains some changes to the original 1997 incentive, including the creation of a fund to study “off-patent” drugs in children, the establishment of an Office of Pediatric Therapeutics at the Food and Drug Administration, and the addition of a toll-free telephone number to drug labels for consumers to report adverse drug reactions to the Food and Drug Administration.
The law also requires safety information from pediatric studies to be added to drug labels in a timely manner, requires FDA promptly to share pediatric study information with pediatricians and parents, and ensures that all patented drugs will be studied in children by allowing eligible third parties to study those drugs that the industry sponsors choose not to study.
In addition, the law no longer waives industry user fees for filing pediatric drug application supplements. Under Section 5 of the act, all pediatric supplements requiring FDA to examine clinical data prior to approval must be accompanied by user fees, effective Jan. 4.
Glucophage Provision ExcludedPassage of the pediatric exclusivity bill was considered critical by brand-name drugmakers and many children’s health groups. However, the legislation had been bogged down by attempts by Bristol-Myers Squibb Co. to use an additional three years of “new indication” exclusivity for its diabetes drug, Glucophage. The company wanted to block generic competition for an extra three years in return for changing its label to reflect the results of pediatric testing (No. 239 HCDR 12/14/01 ). But the act passed the Congress without language affording special treatment for Glucophage.
Under Section 11 of the law, generic drug companies will be able to sell their versions of drugs whose labels have been changed to reflect new pediatric information, but the generic firms cannot promote or label their versions for pediatric use until the three years of new indication exclusivity for the pioneer drug expires. However, the generic drugs will have to carry any applicable pediatric safety warnings on their labels.
Generic Drug, Children’s Health GroupsGeneric drugmakers praised Congress and Bush for closing “a loophole over pediatric labeling” in the reauthorized law. “We would like to thank the president for doing his part in helping to bring affordable generics to consumers in a timely manner,” Generic Pharmaceutical Association President William Nixon said in a Jan. 7 statement. “With Section 11 now the law of the land, both Congress and the White House have put the needs of Americans first.”
Kate Carr, president and chief executive officer of the Elizabeth Glaser Pediatric AIDS Foundation, said in a Jan. 7 statement that the group was “elated that the President has signed this crucial, pro-child legislation into law.” The foundation was one of the children’s health groups, along with the American Academy of Pediatrics and others, that lobbied for the law’s renewal.
Bristol-Myers Files Citizen PetitionBut the fight over whether “new indication” exclusivity for drugs tested on children can block generic versions of those drugs from entering the market at all may not be over. On Dec. 26, 2001, Bristol-Myers filed a citizen petition with the FDA, asking the agency to review how it will implement Section 11. Because “[t]he differing goals of mandates of section 11 are in tension,” the petition said, “FDA needs to adopt general procedures under Section 11 for considering [abbreviated new drug applications to market generic versions of brand-name drugs] and for determining what types of labeling will protect both the safety of pediatric patients and the legitimate exclusivity rights of innovator drug manufacturers.”
But Clay O’Dell, spokesman for the Generic Pharmaceutical Association, told BNA Jan. 8 that the president’s signing the bill after Bristol-Myers filed its Dec. 26 petition may indicate that the company will not prevail in its latest bid to delay the approval of generic Glucophage.
“It’s all up to FDA,” O’Dell said, characterizing the Bristol-Myers petition as “one last, desperate attempt” to delay generic approval.
A copy of the Bristol-Myers petition is available at: http://www.fda.gov/ohrms/dockets/dailys/01/Dec01/122701/01p-0586_cp00001_vol1.pdf on the Web.
Bush Signs Pediatric Incentive Bill Extending Exclusivity Provision Until 2007
BNA Health Daily Report. (Bureau of National Affairs, USA)
Volume 7 Number 6 Wednesday, January 9, 2002 ISSN 1091-4021
President Bush on Jan. 4 signed into law a bill reauthorizing until 2007 the pediatric exclusivity incentive, which gives drugmakers an additional six months of market exclusivity for testing their drugs in children (Pub. L. No. 107-109).
The reauthorized law, the Best Pharmaceuticals for Children Act (S. 1789), contains some changes to the original 1997 incentive, including the creation of a fund to study “off-patent” drugs in children, the establishment of an Office of Pediatric Therapeutics at the Food and Drug Administration, and the addition of a toll-free telephone number to drug labels for consumers to report adverse drug reactions to the Food and Drug Administration.
The law also requires safety information from pediatric studies to be added to drug labels in a timely manner, requires FDA promptly to share pediatric study information with pediatricians and parents, and ensures that all patented drugs will be studied in children by allowing eligible third parties to study those drugs that the industry sponsors choose not to study.
In addition, the law no longer waives industry user fees for filing pediatric drug application supplements. Under Section 5 of the act, all pediatric supplements requiring FDA to examine clinical data prior to approval must be accompanied by user fees, effective Jan. 4.
Glucophage Provision ExcludedPassage of the pediatric exclusivity bill was considered critical by brand-name drugmakers and many children’s health groups. However, the legislation had been bogged down by attempts by Bristol-Myers Squibb Co. to use an additional three years of “new indication” exclusivity for its diabetes drug, Glucophage. The company wanted to block generic competition for an extra three years in return for changing its label to reflect the results of pediatric testing (No. 239 HCDR 12/14/01 ). But the act passed the Congress without language affording special treatment for Glucophage.
Under Section 11 of the law, generic drug companies will be able to sell their versions of drugs whose labels have been changed to reflect new pediatric information, but the generic firms cannot promote or label their versions for pediatric use until the three years of new indication exclusivity for the pioneer drug expires. However, the generic drugs will have to carry any applicable pediatric safety warnings on their labels.
Generic Drug, Children’s Health GroupsGeneric drugmakers praised Congress and Bush for closing “a loophole over pediatric labeling” in the reauthorized law. “We would like to thank the president for doing his part in helping to bring affordable generics to consumers in a timely manner,” Generic Pharmaceutical Association President William Nixon said in a Jan. 7 statement. “With Section 11 now the law of the land, both Congress and the White House have put the needs of Americans first.”
Kate Carr, president and chief executive officer of the Elizabeth Glaser Pediatric AIDS Foundation, said in a Jan. 7 statement that the group was “elated that the President has signed this crucial, pro-child legislation into law.” The foundation was one of the children’s health groups, along with the American Academy of Pediatrics and others, that lobbied for the law’s renewal.
Bristol-Myers Files Citizen PetitionBut the fight over whether “new indication” exclusivity for drugs tested on children can block generic versions of those drugs from entering the market at all may not be over. On Dec. 26, 2001, Bristol-Myers filed a citizen petition with the FDA, asking the agency to review how it will implement Section 11. Because “[t]he differing goals of mandates of section 11 are in tension,” the petition said, “FDA needs to adopt general procedures under Section 11 for considering [abbreviated new drug applications to market generic versions of brand-name drugs] and for determining what types of labeling will protect both the safety of pediatric patients and the legitimate exclusivity rights of innovator drug manufacturers.”
But Clay O’Dell, spokesman for the Generic Pharmaceutical Association, told BNA Jan. 8 that the president’s signing the bill after Bristol-Myers filed its Dec. 26 petition may indicate that the company will not prevail in its latest bid to delay the approval of generic Glucophage.
“It’s all up to FDA,” O’Dell said, characterizing the Bristol-Myers petition as “one last, desperate attempt” to delay generic approval.
A copy of the Bristol-Myers petition is available at: http://www.fda.gov/ohrms/dockets/dailys/01/Dec01/122701/01p-0586_cp00001_vol1.pdf on the Web.
Copyright © 2002 by The Bureau of National Affairs, Inc., Washington D.C.
